DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s cancellation of claim 4, amendment of claims 1 and 6, in the paper of 7/29/2026, is acknowledged. Applicants' arguments filed on 7/29/2026, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Claims 1, 4, 6, 7, 11, 13, 15, 16 and 17 are still at issue and are present for examination.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-10 and 13, drawn to an alpha amylase variant, in the paper of 3/20/2026, is acknowledged. Applicants traverse the restriction requirement on the basis that applicants submit that there would not be a serious burden on the examiner if restriction were not required. Applicants complete traversal is acknowledged and has been carefully considered, however, is not found persuasive for the reasons previously made of record. As previously stated, the groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: Where a group of inventions is claimed in an application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression "special technical features" shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. In the instant case WO 2016/180749 discloses an alpha amylase variant which has improved performance and at least 65% sequence identity to the alpha amylase of SEQ ID NO:3 and a substitution at two or more positions corresponding to 181, 182, 183 and 184 and an alteration at one or more (e.g., several) positions corresponding to position: 54, 109, 172, 174, 195, 206, 391, 473 and 476, using SEQ ID NO: 3. See also below rejections based upon anticipation. Thus, the shared technical feature is not special and unity of invention is lacking.
Further a serious burden would be on the examiner if the restriction was not required on the basis of the additional search that would be required to search the additional groups.
Applicant's election with traverse of the following species:
Species Group 1: elect positions 182 and 183
Species Group 2: elect position 54
Species Group 3: elect the polypeptide of SEQ ID NO: 1
Species Group 4: elect the increased thermostability:
Species Group 5: elect G182* + D183*
Species Group 6: elect position 1
Species Group 7: elect the group of alterations listed in claim 7 (i)
in the paper of 3/20/2026, is acknowledged
Claims 11 and 15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 101
The rejection of claim 1, 4, 13, 16 and 17 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn based upon applicants amendment of the claims in the paper of 7/29/2026.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The rejection of claim(s) 1, 4, 6, 13, 16 under 35 U.S.C. 102(a)(1) as being anticipated by Andersen et al., WO 2016/180749 is withdrawn based upon applicants amendment of the claims in the paper of 7/29/2026.
The rejection of claim(s) 1, 4, 16 and 17 under 35 U.S.C. 102(a)(1) as being anticipated by Uniprot Accession No. A9YDD9, Aug 2020 is withdrawn based upon applicants amendment of the claims in the paper of 7/29/2026.
Claim(s) 1, 6, 13, 16, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andersen et al. (US 11,319,509; US 10,647,946; US 2020/0299617, and WO 2016/180748).
Andersen et al. (US 11,319,509; US 2020/0299617, and WO 2016/180748) discloses an alpha-amylase variant which has an improved performance, wherein said variant has at least 85% identity to SEQ ID NO: 13, and wherein said variant comprises a deletion at two or more positions corresponding to positions R181, G182, D183, and G184 in SEQ ID NO: 13 and a substitution at one or more positions corresponding to positions N54, G109, Q172, A174, N195, V206, K391, P473, G476 in SEQ ID NO: 13, and uses thereof in a method of cleaning (refer to cl 1-29). It is pointed out that the alpha-amylase corresponding to SEQ ID NO: 13 is 100% identical with the alpha-amylase corresponding to SEQ ID NO: 1 of the present application. Andersen et al. teaches a number of specific combinations of mutants including those listed in claim 14, such as H1*+ N54S + V56T + G109A+R1 16Q + W167F + Q172R + A174S + G182* + D183* + N195F + V206L + A265G + K391A + P473R + G476K (see 26th combination from the bottom of page comprising column 303 and 304 of US 11,319,509).
Thus claim(s) 1, 6, 13, 16, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andersen et al. (US 11,319,509; US 10,647,946; US 2020/0299617, and WO 2016/180748).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 4, 6, 7, 13, 16 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,319,509.. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-26 of U.S. Patent No. 11,319,509 drawn to variant of a parent alpha-amylase having alpha-amylase activity, which: a) is a polypeptide having at least 85% sequence identity to SEQ ID NO: 13 or SEQ ID NO: 14, and b) comprises a substitution or a deletion at a position corresponding to H1 of the amino acid sequence as set forth in SEQ ID NO: 13 or SEQ ID NO: 14, c) has alpha-amylase activity, and d) has an improved wash performance at a low temperature of 5° C. to 40° C., wherein the improved wash performance is an Improvement Factor (IF) of >1, when compared to the parent alpha-amylase comprising the specific combinations of mutants including those listed in claim 14, such as H1*+ N54S + V56T + G109A+R1 16Q + W167F + Q172R + A174S + G182* + D183* + N195F + V206L + A265G + K391A + P473R + G476K anticipate/make obvious instant claims 1, 4, 6, 7, 13, 16 and 17 drawn to an alpha-amylase variant of a parent alpha-amylase, wherein the alpha-amylase variant comprises a) a deletion selected from the group consisting of R181*+G182*, R181* + D183*, R181* + G184*, G182* + D183*, G182* + G184*, or D183* + G184*, using SEQ ID NO: 1 for numbering; b) alterations at positions corresponding to positions: 54, 109, 172, 174, 195, 206, 391, 473 and 476, using SEQ ID NO: 1 for numbering, wherein the alterations are substitutions; and wherein said variant has at least 85%but less than 100% sequence identity to the polypeptide of SEQ ID NO: 1, and wherein said variant has alpha-amylase activity and wherein the said variant has improved wash performance compared to said parent alpha- amylase.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Remarks
No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached on 6-3 EST Mon-Fri.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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rgh
9/17/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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